【正文】 pharmaceuticals, drugs for topical use, and nonprescription drugs. 、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)必須執(zhí)行政府定價(jià)、政府指導(dǎo)價(jià)，不得以任何形式擅自提高價(jià)格。 Other cases where the drug standards are not plied with. 稱。 The indications or functions indicated are beyond the specified scope. 85. 禁止生產(chǎn)、銷售劣藥。 Production (including dispensing) and distribution of counterfeit drugs are prohibited. ，為假藥： A drug falling into the following categories is deemed as a counterfeit drug: （一）藥品所含成份與國(guó)家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的； The ingredients in the drug are different from those specified by the National Drug Standards。 The drug control institution affiliated to the drug regulatory agency of the State Council is responsible for standardizing the National Drug Standard Substance and Reference Substance. 、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營(yíng)資格的企業(yè)購(gòu)進(jìn)藥品；但是，購(gòu)進(jìn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。 The institutions for nonclinical safety evaluation and study and for clinical study institutions shall respectively follow the Good Laboratory Practice for NonClinical Laboratory Studies (GLP) and Good Clinical 6 Practice (GCP). 產(chǎn)新藥或者已有國(guó)家標(biāo)準(zhǔn)的藥品的，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號(hào)；但是，生產(chǎn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)管理的中藥材和中藥飲片除外。 No drugs other than the Chinese crude drugs may be sold at fairs in urban and rural areas, but drug retailers holding the Drug Supply Certificate may, within the specified business scope, sell such drugs at the stores they set up at the fairs. ，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審 核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。 After receiving the drug purchased, drug distributors shall pass the established examination and acceptance system, and check the certificate of drug quality, labels and others marks。 No one is permitted to distribute drugs without the certificate. 48.《藥品經(jīng)營(yíng)許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營(yíng)范圍，到期重新審查發(fā)證。 With the exception of the processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity with the National Drug Standard and with the production processes approved by the drug regulatory agency of the State Council, and the production records shall be plete and accurate. 的，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。 The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reviewing and approval again is required. ，應(yīng)當(dāng) 符合國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。 1 常 用 藥 品 監(jiān) 管 英 語(yǔ) 與 縮 略 語(yǔ) —— 浙江省藥品監(jiān)督管理局政策法規(guī)處 一、監(jiān)管英語(yǔ) 1.《中華人民共和國(guó)藥品管理法》 Drug Control Law of the People39。 Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency for industry and merce. 35.《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。 Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency shall inspect a drug manufacturer as to its pliance with the GMP requirements and issue 3 a certificate to the manufacturer passing the inspection. ，藥品必須按照國(guó)家藥品標(biāo)準(zhǔn)和國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生 產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。 With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and merce. 《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。 The drug regulatory agency inspect a drug distributor as to its pliance with the GSP requirements, and issue a certificate to the distributor passing the inspection. ，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī) 定要求的，不得購(gòu)進(jìn)。 Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council. 5 品，但持有《藥品經(jīng)營(yíng)許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場(chǎng)設(shè)點(diǎn)出售中藥材以外的藥品。 When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council. 機(jī)構(gòu)必須分別執(zhí)行藥物非臨床研 究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。 The drug regulatory agency of the State Council shall anize a pharmacopoeia mission, which shall be responsible for formulating and revising the National Drug Standards. 標(biāo)定國(guó)家藥品標(biāo)準(zhǔn)品、對(duì)照品。 When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from the enterprises to meet the urgent need. 82. 禁止生產(chǎn)（包括配制）、銷售假藥。 （六 ）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。 or （六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。 In the label or insert sheet shall be indicated the adopted name of the drug, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, drug adverse reactions, and precautions. 、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標(biāo)簽，必須印有規(guī)定的標(biāo)志。 No unscientific conclusion or guarantee on drug efficacy is permitted to be included in drug advertisement。 With regard to the drugs produced according to the provisions of this Law by drug manufacturers not located in the region, the local government and drug regulatory agency are not permitted to restrict or refuse their access to the region. 。 The drug regulatory agency of the State Council is responsible for supervision and administration of medical devices nationwide. 。 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available. 器械的使用說(shuō)明書、標(biāo)簽、包裝應(yīng)當(dāng)符合國(guó)家有關(guān)標(biāo)準(zhǔn)或者規(guī)定。 Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Man